Gene Therapy Legislation in the Slovak Republic
The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the deliberate release framework- Part B of Directive 2001/18. Authorization of GMO aspects is required prior to the submission of the clinical trial application.
Additional information can be found at:
- State Institute for Drug Control (SIDC)
Application forms to seek authorisation for the GMO aspects
The details of the application are set in the Decree No. 399/2005 ( http://bch.cbd.int/database/record.shtml?documentid=47486
The Ministry informs the public about applications for approval as well as on issued permits through the Internet (http://www.minzp.sk/postupy-ziadosti/geneticky-modifikovane-organizmy/pripomienky-k-ziadostiam-ohlaseniam/), and by any other appropriate means as well if it is necessary to effectively inform the public, with a call for public comments within a deadline of 30 days.
National authorities involved
Authorization of clinical trials:
The State Institute for Drug Control
Department of Clinical Trials, Kvetná 11, 825 08 Bratislava
Authorisation of GMO aspects:
Ministry of Environment of the Slovak Republic
Department of Environmental Hazards and Biosafety Námestie Ľ. Štúra 1,812 35 Bratislava
(Last reviewed by the Competent Authority: December 2017)